New draft Australian guidelines (on screening and expectant management)

A group of Australian experts has just released new draft guidance on prostate cancer screening and the role of expectant management (active surveillance and/or watchful waiting) in the management of prostate cancer. According to a news item on the Practice Update web site earlier today, this new guidance was issued at the World Cancer Congress currently ongoing in Melbourne, Australia, and the full text of the new guidance is available for comment at this web link.

The core statements of the new guidance, which, after comments on the initial draft, will be submitted to the National Health and Medical Research Council of Australia for its endorsement, read as follows:

 For men without a prostate cancer diagnosis or symptoms that might indicate prostate cancer

  • Offer evidence-based decisional support to men considering whether or not to have a PSA test, including the opportunity to discuss the potential benefits and risks of PSA testing before the decision to test is confirmed.
  • For men informed of the benefits and harms of screening who wish to undergo regular testing, offer PSA testing every 2 years from age 50 to age 69, and offer further investigation if the PSA is greater than 3.0 ng/ml.
  • In asymptomatic men interested in undergoing testing for early diagnosis of prostate cancer, digital rectal examination is not recommended as a routine test in the primary care setting.
  • Do not offer PSA testing to a man who is unlikely to live another 7 years.

Active surveillance and watchful waiting

  • Offer active surveillance to men with prostate cancer who meet all the following criteria — a PSA ≤ 20 ng/ml, clinical stage T1-T2, and Gleason score 6.
  • Advise men with potentially curable prostate cancer considering watchful waiting that their risk of developing more advanced prostate cancer and dying from it will be higher with watchful waiting than with immediate definitive treatment but that, in the medium to long term, watchful waiting is unlikely to diminish their well-being and quality of life.

This new guidance varies in several places from the guidance currently being offered by other organizations in other countries, and therefore adds to the continuing lack of global consensus about the appropriate applications of various methods available for risk assessment and for expectant management.

Whether this new, proposed, Australian guidance is as good, better, or worse than any other guidance currently available is, as always, open for discussion. We have some relatively straightforward observations:

  • An experienced primary care physician really should be able to give patients a DRE. This is not a sophisticated medical procedure, and findings on DRE may be the only factor that can tell a primary care clinician to refer the patient to a urologist for a more careful examination and work-up if he has a low PSA.
  • The selection of life expectancy of 7 years as a cut-off point for whether a man should be given a PSA test appears to be based on no more evidence than the life expectancy of 10 years selected  by others.
  • The criteria of a PSA ≤ 20 ng/ml, clinical stage T1-T2, and Gleason score 6 as the criteria for offering active surveillance appear to be arbitrary, and possibly dangerous. For example, a man with a PSA of 19.9 ng/ml, a clinical stage of T2c, and a Gleason score of 6 on a single, systematic 12-core biopsy may be at high risk for upgrading to Gleason 3 + 4 = 7 or Gleason 4 + 3 = 7 on re-biopsy. Is it really going to be wise to let such a man onto an active surveillance protocol without any further examination of his risk? Many would state that such a patient should — at a minimum — be given a thorough repeat biopsy within 6 months of the first biopsy.
  • At least two major studies have demonstrated that, for men of 65 and older with low-risk disease and “with potentially curable prostate cancer”, watchful waiting presents no greater risk for prostate cancer-specific mortality than any form of active treatment. This raises serious questions about the validity of the final recommendation offered by the panel.

Obviously we shall need to see what comments come back from the community related to this new set of draft guidance. In our humble opinion this guidance still needs a little careful work.

One Response

  1. I have read the paper and my observations turn out to be the same as yours.

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